MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG?; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	H74939171031010
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.G4 - premarket / 510(k): k103751, k110122.Detailed patient outcome information was not provided to bsc.A good faith effort was made to obtain the necessary information; however, no information has been obtained thus far.Should relevant additional details become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that device entrapment occurred.A 3.0 x 100, 135cm mustang balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon became stuck on the jagwire and was very difficult to move or use.The balloon was pulled very hard, resulting to balloon damage.
Event or Problem Description
It was reported that device entrapment occurred.A 3.0 x 100, 135cm mustang balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon became stuck on the jagwire and was very difficult to move or use.The balloon was pulled very hard, resulting to balloon damage.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.G4 - premarket / 510(k): k103751, k110122.Detailed patient outcome information was not provided to bsc.A good faith effort was made to obtain the necessary information; however, no information has been obtained thus far.Should relevant additional details become available, a supplemental report will be submitted accordingly.The device was returned for detailed analysis.Upon visual and tactile inspection, the shaft was found to be stretched at multiple locations along its length, with additional kinking and accordioning noted.According to the mustang specifications, the catheter is designed to accommodate a 0.035-inch (0.89 mm) guidewire.However, during the investigation, a boston scientific 0.035-inch guidewire could not be advanced through the device due to the observed damage to the shaft.The specific guidewire used by the customer was not returned for further evaluation.A visual examination of the returned device revealed that the balloon had been inflated but was not refolded post-use.The timing of when the balloon was subjected to positive pressure is unknown.No defects or issues were identified with the balloon material or its structural integrity.Additionally, a visual assessment of the marker bands confirmed no abnormalities or damage.Finally, a comprehensive visual and tactile examination of the tip identified no damage or irregularities.This incident is reported as a device malfunction potentially impacting performance and safety due to the noted shaft deformation.Further investigation into the root cause of the shaft damage is warranted.

• Brand Name: MUSTANG?
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21989989
• Report Number: 2124215-2025-26707
• Device Sequence Number: 8388846
• Product Code: LIT
• UDI-Device Identifier: 08714729794295
• UDI-Public: (01)08714729794295(17)260811(10)32203251
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2026
• Device Model Number: H74939171031010
• Device Catalogue Number: H74939171031010
• Device Lot Number: 0032203251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown